Systemic and local estrogen metabolism in healthy women compared to endometrial cancer patients

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON25168

Enrollment

Registered

2016-03-20

Start date

2016-05-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

endometrial cancer estrogen metabolism estrone 17beta-estradiol 17beta-hydroxysteroid dehydrogenase steroid sulfatase steroid sulfotransferase aromatase serum hormone levels endometrial tissue

Interventions

Endometrial tissue analysis mRNA analyses will be preformed using real-time PCR. RNA will be isolated with Trizol reagent and assesses spectrophotmetrically for quantity and purity and c DNA will be

frozen samples will be homogenized with a blender in a radioimmunoprecipitation assay buffer, debris will be removed by centrifugation and protein concentration will be determined. The activity of enz

- 17beta-hydroxysteroid dehydrogenase type 1 (HSD17B1) - 17beta-hydroxysteroid dehydrogenase type 2 (HSD17B2) - Steroid sulphatase (STS) - Estrogen sulphotransferase (SULT1E1) - Aromatase (ARO) B

estradiol, cortisol, cortisone, estriol, aldosterone, 17OH-pregnenolone, 11deoxycortisol, estrone, DHEA, testosterone, 17OH-progesterone, androstrome, etiocholanolone, dht, androstenedione, pregnenolo

Eligibility

Inclusion criteria

Inclusion criteria: Patients with; - Hysterectomy needs to be preformed because of endometrial cancer or benign indication (like prolapse, menorrhagia, uterus myomatosis) - Menopausal status is known - Blood collection need to be allowed - Informed consent is given - No history of malignancies in the previous 5 years - Minimum age: 18 years

Exclusion criteria

Exclusion criteria: Patients with; - Neoadjuvant treatment defined as chemotherapy and/or radiotherapy - Aged under 18 years

Design outcomes

Primary

Measure	Time frame
The primary outcome will be the difference between premenopausal, postmenopausal and endometrial cancer patients in the local tissue enzyme mRNA levels analysed by rt-PCR and described as fold change compared to housekeeping genes. Enzyme activity levels analysed by LCMS for HSD17B1, HSD17B2, STS, SULT1E1, ARO will be described in pmol/mg/hour. Systemic serum steroid levels (see for specification section 5.3 study procedures).will be measured and described in ng/ml or pg/ml.	—

Measure

Time frame

The primary outcome will be the difference between premenopausal, postmenopausal and endometrial cancer patients in the local tissue enzyme mRNA levels analysed by rt-PCR and described as fold change compared to housekeeping genes. Enzyme activity levels analysed by LCMS for HSD17B1, HSD17B2, STS, SULT1E1, ARO will be described in pmol/mg/hour. Systemic serum steroid levels (see for specification section 5.3 study procedures).will be measured and described in ng/ml or pg/ml.

—

Secondary

Measure	Time frame
Secondary objectives are; differences in BMI, presence of diabetes, presence of hypertension, hormone use, parity, and history of other malignancies.	—

Contacts

Public ContactKarlijn Cornel

k.cornel@maastrichtuniversity.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)